Recall Z-3020-2026
Medline Industries, LP · initiated July 10, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK, Medline Kit SKU CDS840393Q; 3) OPEN HEART PROCEDURE, Medline Kit SKU CDS980895W; 4) VALVE CDS, Medline Kit SKU CDS981551G; 5) FEM POP, Medline Kit SKU CDS982028W; 6) PACK,OPEN HEART, Medline Kit SKU DYNJ906903F; 7) PACK,CLOSED HEART, Medline Kit SKU DYNJ906904C; 8) ENDOSCOPIC SKULL BASE, Medline Kit SKU DYNJ908362F; 9) OPEN HEART, Medline Kit SKU DYNJ910947; 10) CV, Medline Kit SKU DYNJ911488.
Codes / lots: Medline Kit SKU CDS840393P, UDI/DI 10198459405266 (each) 40198459405267 (case), Lot Number 26FMA487; Medline Kit SKU CDS840393Q, UDI/DI 10198459791673 (each) 40198459791674 (case), Lot Number 26GMA017; Medline Kit SKU CDS980895W, UDI/DI 10198459123542 (each) 40198459123543 (case), Lot Number 25LMG706; Medline Kit SKU CDS981551G, UDI/DI 10198459275814 (each) 40198459275815 (case), Lot Number 25JBY147; Medline Kit SKU CDS981551G, UDI/DI 10198459275814 (each) 40198459275815 (case), Lot Number 25JBR361; Medline Kit SKU CDS982028W, UDI/DI 10198459385605 (each) 40198459385606 (case), Lot Number 25LMH727; Medline Kit SKU DYNJ906903F, UDI/DI 10198459504877 (each) 40198459504878 (case), Lot Number 25JME689; Medline Kit SKU DYNJ906904C, UDI/DI 10198459168499 (each) 40198459168490 (case), Lot Number 25JMF804; Medline Kit SKU DYNJ906904C, UDI/DI 10198459168499 (each) 40198459168490 (case), Lot Number 25IMG539; Medline Kit SKU DYNJ908362F, UDI/DI 10198459308581 (each) 40198459308582 (case), Lot Number 25LLA930; Medline Kit SKU DYNJ908362F, UDI/DI 10198459308581 (each) 40198459308582 (case), Lot Number 25LLA516; Medline Kit SKU DYNJ908362F, UDI/DI 10198459308581 (each) 40198459308582 (case)…
Reason for recall
Kits contain a potentially contaminated component which were recalled by the manufacturer
FDA-determined cause: Process change control
Action taken
Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 7/1/2026 via USPS and email. The notice explained the issue, potential hazard, and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-120-FG-FGX2 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product." For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Details
- Recall number
- Z-3020-2026
- Initiated
- July 10, 2026
- Posted by FDA
- August 26, 2026
- Product code
- OEZ – Cardiovascular Procedure Kit
- Quantity
- 263 kits
- Distribution
- US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.
- Recalling firm
- Medline Industries, LP, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3019-2026 Class II | Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer | 07/10/2026Open, Classified |
| Z-3021-2026 Class II | Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991SKits contain a potentially contaminated component which were recalled by the manufacturer | 07/10/2026Open, Classified |
| Z-3022-2026 Class II | Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer | 07/10/2026Open, Classified |
| Z-3023-2026 Class II | Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375MKits contain a potentially contaminated component which were recalled by the manufacturer | 07/10/2026Open, Classified |
| Z-3024-2026 Class II | Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer | 07/10/2026Open, Classified |
| Z-3025-2026 Class II | Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer | 07/10/2026Open, Classified |
| Z-3026-2026 Class II | Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer | 07/10/2026Open, Classified |
| Z-3027-2026 Class II | Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN…Kits contain a potentially contaminated component which were recalled by the manufacturer | 07/10/2026Open, Classified |
| Z-3028-2026 Class II | Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU…Kits contain a potentially contaminated component which were recalled by the manufacturer | 07/10/2026Open, Classified |
| Z-3029-2026 Class II | Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON…Kits contain a potentially contaminated component which were recalled by the manufacturer | 07/10/2026Open, Classified |